Kalypsys, a clinical-stage pharmaceutical company, has implemented Xerox DocuShare® CPX enterprise content management software to electronically manage the extensive documentation associated with drug development and testing, which is required by the U.S. Food and Drug Administration (FDA).
Xerox DocuShare™, along with the DocuShare Compliance Module from Sitrof Technologies Inc., is helping Kalypsys capture, store, share, update and approve the thousands of documents created during a clinical trial in compliance with the FDA’s 21 CFR Part 11 regulations governing electronic records and electronic signatures for pharmaceutical and life sciences industries.

For example, study protocol documents-extensive instructions that explain how a drug is going to be administered-follow a specific workflow sequence that includes multiple revisions and approvals. Should the FDA request proof of compliance, DocuShare CPX and the DocuShare Compliance Module enable Kalypsys to easily produce a full record of the document history, complete with notes to explain changes, as well as electronic approval signatures.

“Many companies often don’t address requirements for FDA compliance until clinical trials are well underway and paper-based document tracking processes have become overwhelming,” said Dr. Paul Grint, chief medical officer of Kalypsys. “We partnered with DocuShare and Sitrof because their intuitive, cost-effective content management and compliance offering gives us the ability to quickly organize and deliver the documentation required by the FDA, leaving us to maintain our focus and priority on the testing at hand.”

In addition to managing the content associated with clinical studies, Kalypsys is using DocuShare to develop the documentation for IT projects and control financial reporting activities. Researchers and other employees can utilize the Web-based application to share content with outside partners including other pharmaceutical firms and university-based research organizations.

“The pharmaceutical and life sciences industries face a particularly tough challenge given the multitude of documentation and auditing demands they’re presented with for compliance,” said David Smith, vice president, Xerox DocuShare Business Unit. “The combination of Xerox’s innovative and customizable platform with Sitrof’s in-depth industry knowledge and integration ensures that DocuShare CPX meets the critical needs of pharmaceutical companies like Kalypsys.”

Already a significant number of Kalypsys employees, including researchers, are using the Xerox/Sitrof compliance solution, and the company is looking to continue implementing DocuShare CPX capabilities to perform tasks such as archiving e-mail and tracking contracts in other areas of the business including HR, Legal and Finance.

Sitrof Technologies will be demonstrating its DocuShare CPX compliance solution at their booth No. 655 at the 43rd annual meeting of the Drug Information Association (DIA). The meeting will be held from June 17-20 in Atlanta, GA.